BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT

    MDR report key: 1981601 · Received February 8, 2011

    Report

    Report Number
    2939204-2011-00061
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THROMBOSIS AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    FOLLOWING INTRA-ARTERIAL INFUSION OF INTEGRILIN, ANGIOPLASTY WAS PERFORMED TO REPERFUSE THE OCCLUDED DISTAL LEFT V4 VERTEBRAL ARTERY (VA), PROXIMAL AND MID BASILAR ARTERY (BA). THE BALLOON WAS GENTLY INFLATED THREE TIMES TO SIX ATMOSPHERES. FOLLOW-UP ANGIOGRAPHY SHOWED IMPROVEMENT OF BASILAR FLOW; HOWEVER, THERE WAS RECURRENT PROXIMAL BASILAR THROMBOSIS AND A VESSEL DISSECTION WITH NO FORWARD FLOW INTO THE BA. THE STENT WAS PLACED ACROSS A DISEASED VERTEBRO-BASILAR STENOTIC LESION. SUBSEQUENT FOLLOW UP ANGIOGRAPHY REVEALED PERSISTENT OCCLUSION OF THE BA. IN-STENT ANGIOPLASTY WAS PERFORMED AND INTEGRILIN WAS INFUSED WITH NO IMPROVEMENT. AS THE SITE OF PERSISTENT OCCLUSION APPEARED TO BE CENTERED AT THE PROXIMAL TINES OF THE STENT, A SECOND STENT WAS DEPLOYED OVERLAPPING THE PROXIMAL TINES OF THE FIRST STENT. FINAL STENT DEPLOYMENT WAS COMPLICATED BY AN ACUTE IN-STENT THROMBOSIS REQUIRING FURTHER INTRA-ARTERIAL THROMBOLYSIS. FOLLOWING INFUSION OF INTEGRILIN AND TISSUE PLASMINOGEN ACTIVATOR (TPA) WITHIN THE IN-STENT THROMBUS, BA RECANALIZATION WAS ACHIEVED. HOWEVER, POST PROCEDURE THE PATIENT'S CLINICAL CONDITION WAS EXTREMELY POOR. IMAGING REVEALED PONTINE, CEREBELLAR AND LEFT THALAMIC INFARCTS. THREE DAYS POST PROCEDURE THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED TEN MINUTES LATER AFTER BEING EXTUBATED.

    Description of Event or Problem · 1

    FOLLOWING INTRA-ARTERIAL INFUSION OF INTEGRILIN, ANGIOPLASTY WAS PERFORMED TO REPERFUSE THE OCCLUDED DISTAL LEFT V4 VERTEBRAL ARTERY (VA), PROXIMAL AND MID BASILAR ARTERY (BA). THE BALLOON WAS GENTLY INFLATED THREE TIMES TO SIX ATMOSPHERES. FOLLOW-UP ANGIOGRAPHY SHOWED IMPROVEMENT OF BASILAR FLOW; HOWEVER, THERE WAS RECURRENT PROXIMAL BASILAR THROMBOSIS AND A VESSEL DISSECTION WITH NO FORWARD FLOW INTO THE BA. THE STENT WAS PLACED ACROSS A DISEASED VERTEBRO-BASILAR STENOTIC LESION. SUBSEQUENT FOLLOW UP ANGIOGRAPHY REVEALED PERSISTENT OCCLUSION OF THE BA. IN-STENT ANGIOPLASTY WAS PERFORMED AND INTEGRILIN WAS INFUSED WITH NO IMPROVEMENT. AS THE SITE OF PERSISTENT OCCLUSION APPEARED TO BE CENTERED AT THE PROXIMAL TINES OF THE STENT, A SECOND STENT WAS DEPLOYED OVERLAPPING THE PROXIMAL TINES OF THE FIRST STENT. FINAL STENT DEPLOYMENT WAS COMPLICATED BY AN ACUTE IN-STENT THROMBOSIS REQUIRING FURTHER INTRA-ARTERIAL THROMBOLYSIS. FOLLOWING INFUSION OF INTEGRILIN AND TISSUE PLASMINOGEN ACTIVATOR (TPA) WITHIN THE IN-STENT THROMBUS, BA RECANALIZATION WAS ACHIEVED. HOWEVER, POST PROCEDURE THE PATIENT'S CLINICAL CONDITION WAS EXTREMELY POOR. IMAGING REVEALED PONTINE, CEREBELLAR AND LEFT THALAMIC INFARCTS. THREE DAYS POST PROCEDURE, THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED TEN MINUTES LATER AFTER BEING EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WS0350150 13446987

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R AGILITY 14 GUIDEWIRE (CODMAN)| MARKSMAN CATHETER (EV3)| GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)| SYNCHRO STANDARD 014 GUIDEWIRE (BOSTON SCIENTIFIC)| EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)| 16.5MG OF INTEGRILIN| TWO THOUSAND UNITS OF HEPARIN